Salvage radiotherapy (SRT) and androgen-deprivation therapy (ADT) are widely used in routine clinical practice to treat patients with prostate cancer who develop biochemical recurrence (BCR) after radical prostatectomy (RP). However, there is no standard-of-care consensus on optimal duration ADT. Investigators propose three distinct risk groups in patients with prostate cancer treated with SRT in order to better define the indications and duration of ADT combined with SRT.
The URONCOR 06-24 trial (ClinicalTrials.gov identifier NCT05781217) is a prospective, multicentre, randomised, open-label, phase III, clinical trial. The aim of the trial is to determine the impact of short-term (6 months) vs long-term (24 months) ADT in combination with SRT on distant metastasis-free survival (MFS) in patients with prostate cancer with BCR after RP (intermediate and high risk).
The primary endpoint is 5-year MFS rates in patients with prostate cancer treated with long- vs short-term ADT in combination with SRT. Secondary objectives are biochemical-relapse free interval, pelvic progression-free survival, time to start of systemic treatment, time to castration resistance, cancer-specific survival, overall survival, acute and late toxicity, and quality of life.
Total of 534 patients will be randomised 1:1 to ADT 6 months or ADT 24 months with a luteinizing hormone-releasing hormone analogue in combination with SRT, stratified by risk group and pathological lymph node status.
The study is conducted under the guiding principles of the World Medical Association Declaration of Helsinki. The results will be disseminated at research conferences and in peer-reviewed journals.
EudraCT number 2021-006975-41.
BJU international. 2024 Jul 23 [Epub ahead of print]
Carmen González-San Segundo, Fernando López Campos, Alfonso Gómez Iturriaga, Aurora Rodríguez, Jesús Olivera, Víctor Duque-Santana, Gemma Sancho, Iván Henríquez, Antonio José Conde, Jeannette Valero, Xavier Maldonado, Luis Glaria, Begoña Caballero, Noelia Sanmamed, Joel Mases, Anna María Boladeras-Inglada, Miguel Montijano, Marina Santos, Ana Álvarez, Juan I Martínez, Felipe Couñago
Department of Radiation Oncology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Department of Radiation Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain., Department of Radiation Oncology, Hospital Universitario Cruces, Biobizkaia Health Research Institute Basque Country University UPV/EHU, Barakaldo, Spain., Department of Radiation Oncology, Hospital Ruber Internacional, Madrid, Spain., Department of Radiation Oncology, Hospital Fundación Jiménez Díaz, Madrid, Spain., Department of Radiation Oncology, Hospital Quironsalud Madrid, Madrid, Spain., Department of Radiation Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Department of Radiation Oncology, Hospital Universitario Sant Joan, Reus, Tarragona, Spain., Department of Radiation Oncology, Hospital Universitario La Fe, Valencia, Spain., Department of Radiation Oncology, Hospital Universitario HM San Chinarro, Madrid, Spain., Department of Radiation Oncology, Hospital Universitario Vall d'Hebron, Barcelona, Spain., Department of Radiation Oncology, Hospital Universitario La Paz, Madrid, Spain., Department of Radiation Oncology, Hospital Universitario de Fuenlabrada, Madrid, Spain., Department of Radiation Oncology, Hospital Universitario Clínico San Carlos, Madrid, Spain., Department of Radiation Oncology, Hospital Universitario Clínic de Barcelona, Barcelona, Spain., Department of Radiation Oncology, Hospital Universitario ICO-L'Hospitalet, Barcelona, Spain., Department of Urology, Hospital Universitario Puerta de Hierro, Madrid, Spain., Department of Radiation Oncology, GenesisCare Hospital San Francisco de Asís, Hospital Vithas La Milagrosa, Madrid, Spain.